NCT01975168

Brief Summary

A randomized double-blind placebo-controlled crossover trial is conducted. 200 subjects aged above 20 years with body mass index (BMI) more than 25 kg/m2 are randomly divided into 2 groups (Group 1 and Group 2). Group 1 receives laser acupuncture therapy first while Group 2 receives sham laser acupuncture therapy first. After 12 weeks of treatment and 14 days of washout, Group 1 switch to sham laser acupuncture therapy while Group 2 switch to laser acupuncture for 12 weeks. The subjects are treated with a gallium aluminum arsenide Handylaser Trion, which is used to apply at each of the acupuncture points for 10 seconds every time, 3 times per week. The measurements of outcomes are performed in the beginning, weekly during treatment, and monthly after treatment for 3 months.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 4, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

November 6, 2013

Status Verified

November 1, 2013

Enrollment Period

1.8 years

First QC Date

October 23, 2013

Last Update Submit

November 5, 2013

Conditions

Obesity

Keywords

laser acupunctureobesity

Outcome Measures

Primary Outcomes (1)

  • body composition

    body weight

    12 weeks

Secondary Outcomes (1)

  • body mass index

    12 weeks

Other Outcomes (5)

  • waist circumference

    12 weeks

  • hip circumference

    12 weeks

  • body fat

    12 weeks

  • +2 more other outcomes

Study Arms (2)

Group 1

EXPERIMENTAL

arrange laser acupuncture intervention for 12 weeks, then cross over to sham laser acupuncture intervention for 12 weeks

Device: Handylaser Trion laser acupuncture

Group 2

SHAM COMPARATOR

arrange sham laser acupuncture for 12 weeks, then cross over to laser acupuncture for 12 weeks

Device: Handylaser Trion laser acupuncture

Interventions

Handylaser Trion laser acupunctureDEVICE

intervention interval is 3 times per week for 12 weeks

Also known as: Handylaser Trion
Group 1Group 2

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body Mass Index over 25 kg/m2 or Waist girth over 80cm in female, waist girth over 90cm in male

You may not qualify if:

  • Pathmakers user
  • Epilepsy history
  • Pregnancy
  • Immuno-inhibiting agents user
  • Malignancy
  • Skin contacted disease
  • Weight controlled agents user during trial period
  • Eating disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese Medicine Department Clinic, Kaohsiung Medical University

Kaohsiung City, Taiwan

RECRUITING

Related Publications (1)

  • Wozniak P, Stachowiak G, Pieta-Dolinska A, Oszukowski P. Laser acupuncture and low-calorie diet during visceral obesity therapy after menopause. Acta Obstet Gynecol Scand. 2003 Jan;82(1):69-73. doi: 10.1034/j.1600-0412.2003.820113.x.

    PMID: 12580844BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Cheng-Che Lin, MD

    Doctor of Chinese Medicine Department, Kaohsiung Medical University Hospital

    STUDY CHAIR

  • Hung-Yi Chuang, ScD, MD

    Department of Public Health, College of Health Sciences, Kaohsiung Medical University

    STUDY DIRECTOR

  • Chen-Cheng Yang, MD

    Family Medicine Department, Kaohsiung Medical University Hospital and Kaohsiung Municipal Ta-Tung Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheng-Che Lin, MD

CONTACT

+8863121101abcmacoto@gmail.com

Chen-Cheng Yang, MD

CONTACT

+886929919132cheng10042001@yahoo.com.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of Chinese Medicine Department

Study Record Dates

First Submitted

October 23, 2013

First Posted

November 4, 2013

Study Start

September 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

November 6, 2013

Record last verified: 2013-11

Locations

TW(1)